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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device differential rate kinetic method, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeJHS
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2018 6 6
2019 6 6
2020 13 13
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 15 15
Low Test Results 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Jan-05-2021
2 Ortho-Clinical Diagnostics II May-08-2020
3 Siemens Healthcare Diagnostics, Inc II Oct-15-2018
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